The Sonic Window is intended for the visualization of vasular access guidance of needles and catheters (Insertion of Peripheral Intravenous (PIV) Catheters as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only.

Device Description

The Sonic Window is a fully integrated handheld ultrasound imaging system that combines electronics, transducer, display and battery into the same device. The device is designed and optimized to visualize real-time ultrasound images on a Coronal (Constant Imaging Depth) plane positioned at a distance (depth) from the transducer that is controllable by the user.

AI/ML Overview

The Sonic Window device is an integrated handheld ultrasound imaging system designed for the visualization of peripheral vessels and assessment of vessel width and depth for needle/catheter placement. It is intended for use by medical professionals via prescription.

There is no study described that proves the device meets specific acceptance criteria based on metrics like sensitivity, specificity, or accuracy for its intended clinical use. The document primarily focuses on non-clinical testing for safety and technical equivalence to predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Acoustic Output	Ispta.3 ≤ 720 mW/cm²	3.4 mW/cm²
	MI ≤ 1.9	0.29
	TI Type: TIS	TIS
	TI Value: Not specified, but within limits (implied by MI/Ispta.3)	0.16
	IPA.3 at MImax: Not specified, but within limits	7.3 W/cm²
Electrical Safety	Compliance with IEC 60601-1 (including Amendments 1 & 2)	Stated compliance
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2: 2001 (Group 1 Class B)	Stated compliance
Programmable Electrical Medical Systems (PEMS)	Compliance with IEC 60601-1-4	Stated compliance
Mechanical Integrity	Withstand mechanical shock and vibration (IEC 60068 series)	Stated compliance
Shipping Durability	Packaging withstands shipping (ISTA Project 2A)	Stated compliance
Altitude Performance	Operation unaffected at higher altitudes	Stated compliance
Material Robustness & Cleaning Resistance	Enclosure material robustness and resistance to cleaning materials	Stated compliance

Study Details:

Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical engineering and safety tests, not a clinical test set with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance was not established as part of the described non-clinical testing.
Adjudication method for the test set: Not applicable. No clinical test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an ultrasound system, not an AI-assisted diagnostic tool as described in this document.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device.
The type of ground truth used: For the non-clinical tests, the "ground truth" was based on established engineering and safety standards (e.g., maximum permissible acoustic output, compliance with IEC standards for electrical safety and EMC, mechanical and environmental endurance specifications).
The sample size for the training set: Not applicable. This document does not describe machine learning or AI components requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

APR 0 4 2014

Image /page/0/Picture/2 description: The image shows the logo for Analogic. The logo consists of the word "analogic" in a simple, sans-serif font, with the tagline "Innovative Solutions for Life" underneath in a smaller font. To the right of the word, there is a circular graphic with an abstract design.

510(k) Summary For Analogic Corporation

Sonic Window

Date this Summary was Prepared: 1.

January 30, 2014

Submitter's Name and Address: 2.

Submitter's Name:	Analogic Corporation
Address:	8 Centennial Drive
City, State, and Zip:	Peabody, Massachusetts 01960
Registration Number:	1220672

Contact Person: 3.

Name:	Albert C. Cefalo
Title:	Senior Manager Global Regulatory Affairs
Telephone:	(978) 326-4000
Facsimile:	(978) 977-6803
E-mail:	cccfalo@analogic.com

4. Device Name:

Proprietary or Trade Name:	Sonic Window
Common Name:	Ultrasound System
Model Name:	SW1000
Classification Name:	Ultrasonic Pulsed Echo Imaging System
Classification Panel:	Ultrasonic Imaging Devices
Product Codes:	IYO, ITX
Code of Federal Regulations:	892.1560, 892.1570

{1}------------------------------------------------

Regulatory Classification of Sonic Window

Device Panel	CFRSection	ProductCode	DeviceClass	Description
Part 892-RadiologyDevices	892.1560	IYO	II	Ultrasonic Pulsed EchoImaging System
Part 892-RadiologyDevices	892.1570	ITX	II	Diagnostic UltrasoundTransducer

ડ. Predicate Devices:

The legally marketed devices to which equivalence is being claimed are:

The Flex Focus cleared under Premarket Notification K 100919 (Summary is included in Appendix C along with the User Guide, the Transducer User Guide and Transducer Data Sheet). This predicate device was chosen specifically for its use on peripheral vascular viewing and its ability to perform in C-Mode with the assistance of additional software. Additionally the BK Model Flex Focus Ultrasound Transducer Probe 8848 (cleared under K081154) was chosen as this predicate probe uses the same patient contact materials.

6. Description of Sonic Window

7. Intended Use:

Visualization of peripheral vessels and assessment of vessel width and depth for needle/catheter placement by a medical professional. The Sonic Window is only intended to be used by a health care professional by prescription only.

{2}------------------------------------------------

Comparison of Technological Characteristics: 8.

The technological characteristics of the Sonic Window are the same as the legally marketed predicate devices.

The Sonic Window Acoustic Output controls are similar to the Output controls of the predicate device. The system will assure that the acoustic output always will stay well below the pre-amendment upper limits ice 15pa ≤ 720mW/cm2 and MI ≤ 1.9 (Track 3, non-ophthalmic.

The Track 3 summary table as required by the FDA guidance document Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; issued September 9, 2008 is provided below.

TransducerModel	Ispta.3	TIType	TIValue	MI	IPA.3 at MImax
SonicWindow	3.4mW/cm²	TIS	0.16	0.29	7.3 W/cm²

{3}------------------------------------------------

Summary of Technological Characteristics - Predicate Device Compared to Modified Device

Manufacturer	Analogic	BK Medical
	Sonic Window	Flex Focus
	New Device	K100919 w/ 8820E
Features	Indications	K081154 for ContactMaterials (Probe 8848)
	Primary Market	Peripheral Vascular	Surgery, Anesthesia &Interventional Radiologyincluding PeripheralVascular
Type Of System		Handheld	Portable
Operating Modes		C-Mode [1]	B, M, Doppler, CFM, PW,THI, 3D/2/
Source Of Power	Battery	Line and Battery
Transducers	Integrated 5MHz 2DArray	Multiple multi-frequencyprobes
	Contact Materials	TPX MX 002, PolymicsCarbon Black	TPX MX 002, PolymicsCarbon Black
Transducer Housing		Radel R-5100	TBD

[1] C (Coronal)-Mode. (Constant Distant Imaging Plane) in real-time

[2] 3D includes the functionality to visualize Coronal planes

[3] Indicates output of Peripheral Vascular Access Probe Model 4C-RS

9. Non-clinical Tests to be used in Determination of Substantial Equivalence:

Prior to marketing the Sonic Window, verification testing activities will be conducted to establish the compliance, performance, and reliability characteristics of the Sonic Window. This is to include the following non-clinical tests:

IEC 60601-1 (including Amendments 1 & 2), Medical Electrical Equipment - General Requirements for Safety

IEC 60601-1-2: 2001 Medical electrical equipment - Electromagnetic compatibility emission limits meet Group 1 Class B

IEC 60601-1-4: Medical electrical equipment - Part 1: General requirements for safety -4. Collateral standard: Programmable electrical medical systems

Mechanical shock and vibration tests will be performed in accordance with IEC 60068 series of standards to ensure the device withstands shocks and vibrations in environment of intended use.

{4}------------------------------------------------

K140126
Page 5 of 5

Shipping container transportation tests will be performed in accordance with ISTA; Project 2A to ensure packaging of equipment is not adversely affected during shipping.

Altitude tests will be performed to ensure that operation at higher altitudes does not adversely affect electrical safety or performance.

Tests will be performed to verify enclosure material robustness and resistance to cleaning materials commonly used in hospitals.

10. Conclusions from Non-clinical Testing:

The test schedule of the Sonic Window combined with "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; issued September 9, 2008," Track 3 tests already performed demonstrate that the performance of the Sonic Window ultrasound system is substantially equivalent to the predicate devices cited in Paragraph 5 of this summary. The device will present no new concerns regarding safety and effectiveness.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Goby

Silver Spring, MD 20993-0002

Public Health Service

April 4, 2014 .

Analogic Corporation % Mr. Albert Cefalo Senior Manager. Global Regulatory Affairs 8 Centennial Drive PEABODY MA 01960

Re: K140126

Trade/Device Name: Sonic Window Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: January 31, 2014 Reccived: February 3, 2014

Dear Mr. Cefalo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not miskeading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be Tound in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (2 l CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{6}------------------------------------------------

Page 2-Mr. Cefalo

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/industry/default.htm.

Sincerely yours,

Samhyl)

for

Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140126

Device Name Sonic Window

Indications for Use (Describe)

Sonic Window / SW1000

Mode of Operation

Clinical Application Other* (Specify)

Nº Peripheral Vascular

= Coronal Plane (Constant Imaging Depth Plane)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Please do not write below this line – continue on a separate page if needed.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

{8}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.